Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01741987
Collaborator
(none)
100
1
2
82
1.2

Study Details

Study Description

Brief Summary

The purpose of this project is to determine the effectiveness of an eyewash osmoprotective lubricant comparing to castor oil containing and non-osmoprotective lubricants in different types of DTS and post refractive surgery patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Optive ®
  • Other: Fresh Tears ®
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
An Effectiveness of Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome (DTS) and Post Refractive Surgery Patients
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: optive® eye drop

Other: Fresh Tears ®
instilation of eye drop 4 times a day (qid)

Placebo Comparator: fresh tears ® eye drop

Other: Optive ®
instilation of 1 drop each eye 4 times per day

Outcome Measures

Primary Outcome Measures

  1. patients satisfaction with osmoprotective lubricant on different types DTS. [3 months]

Secondary Outcome Measures

  1. Our purpose is to determine the differential effects of Optive® castor oil Endura ® on different types DTS. [3 months]

  2. Physician satisfaction with Optive® [3 months]

Other Outcome Measures

  1. Our purpose is to determine the differential effects of Optive® vs. FreshTears ® on post refractive surgery patients. [3 monthas]

  2. change from baseline in Ocular Surface Disease Index (OSDI) [3 moths]

  3. change from baseline in tear break up time (BUT) [3 mothas]

  4. change from baseline in lissamine green staining [3 months]

  5. change form baseline in impression cytology [3 months]

  6. change from baseline in tear osmolarity [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Adult patients willing and able to comply with the protocol who are not planning changes in diet, topical or systemic drugs during the course of study.

  2. DTS all the patients will be diagnosed for mild to moderate evaporative dry eye as defined by following criteria that will be given by Outcome measurements:

2.1. Break up time. 2.2. Lissamine green staining. 2.3. OSDI and Patient Symptomatology Questionnaire.

  1. The patients, whose are going to be submitted for refractive surgery.
Exclusion Criteria:
  1. Any patient with punctual occlusion or punctual plugs.

  2. Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, history of retinal detachment, concurrent contact lens use during trial period,

  3. Patients with glaucoma, anterior membrane dystrophy, active trichiasis or any eyelid globe malposition abnormality.

  4. Patients with Epiphora.

  5. Patients must not have participated in any investigational therapeutic drug or device trial within the 30 days prior to their start date for this trial.

  6. Any patient suffering from organic brain syndromes or major psychiatric disorder that would interfere with compliance or subjective reporting will be discouraged from participating in this trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology, UNIFESP&EPM Sao Paulo SP Brazil

Sponsors and Collaborators

  • Federal University of São Paulo

Investigators

  • Principal Investigator: Rossen M Hazarbassanov, MD, Department of Ophtahlmology, UNIFESP& EPM, Sao Paulo, SP, Brazil

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rossen Mihaylov Hazarbassanov, MD, PhD, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01741987
Other Study ID Numbers:
  • 1346/08
First Posted:
Dec 5, 2012
Last Update Posted:
Feb 16, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2017